Kai Dallas, Colby P Souders, Ashley Caron, Khasiah Clark, Ndidiamaka Obi, Lynn McClelland, Bilal Chughtai, Karyn S Eilber, Jennifer T Anger
OBJECTIVE: The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. METHODS: All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury...
April 15, 2022: Female Pelvic Medicine & Reconstructive Surgery